ISO 13485 certification in Malaysia is an international standard it specifies requirement for a Quality Management System for Medical devices. ISO 13485 standard can be implemented by any organization which are involved in design, manufacturing, support and servicing of medical devices.
Clause 6 sets out the requirement to provide the resources necessary for an effective QMS you have to identify the people and the jobs affecting product quality and ensure that these people are competent. You have to provide the infrastructure and the work environment needed to ensure medical device safety and performance such as health, cleanliness and closing requirements where these could affect product quality where applicable. You have to establish arrangements to prevent contamination, if you have products meeting this kind of control.
Clause 7 contains a very large set of requirements covering the whole of operations, starting with having to plan and develop the processes needed for product realization. First you have to set product quality objectives. Identify product realization requirements and establish arrangements for communicating with customers and medical device regulators. You also have to establish design and develop procedures and organize design and development activities. Effective verification and validation is a very important requirement at this stage prior to design transferred to manufacturing. Then you have to document procedures to control purchasing such as
Clause 7 also requires that you plan monitor and control production and service provision. Define requirements for contamination control if that is applicable in manufacturing and storage and document product installation and verification requirements. Finally, you have to develop servicing procedures and reference materials. Validate processes used for production and service provision, where inspection is not possible and enable product identification and traceability, which may be vital in recalls.
ISO 13485 standard spotlights on the control of the workplace that the clinical field must deal with when any clinical gadget is executed on the site. ISO 13485 certification in Malaysia guarantees the flawless usage so that there will be zero which association with regards to satisfying the models which depend on the total fulfillment of the client.